Orexigen announced the results of all four of its Phase 3 trials in the Contrave Obesity Research, or COR, program in 2009. Each trial met its co-primary endpoints. Data from these trials demonstrated the following:
-- In the COR-I and COR-II trials, approximately 48% and 56% of patients on Contrave32 lost at least 5% of their body weight after 56 weeks on an intent-to-treat basis, as compared to placebo patients who lost approximately 16% and 17% (p<0.001). Additionally, approximately 34% to 48% of patients who completed one year of therapy on Contrave32 in these two trials lost at least 10% of their baseline body weight. -- In the COR-BMOD trial, which incorporated an intensive diet and exercise behavior modification regimen, approximately 55% of patients who completed one year of therapy on Contrave32 lost at least 10% of their baseline body weight. -- In the COR-Diabetes trial, patients with type 2 diabetes taking Contrave lost significantly more weight than patients on placebo, and they also achieved substantial improvements in glycemic control. Specifically, Contrave patients showed a 0.6% reduction in hemoglobin A1c (HbA1c) from baseline, compared to a 0.1% reduction in placebo. -- Key secondary endpoints met across the entire COR Phase 3 program included significant improvements in markers of cardiometabolic risk such as waist circumference, HDL cholesterol and triglycerides. Additional analyses indicate that Contrave patients experienced an increased ability to control their eating compared to placebo. -- Contrave was generally well tolerated by patients across the COR Phase 3 program. The most frequently observed treatment-emergent adverse events were nausea, constipation and headache. Nausea was the leading adverse event resulting in discontinuation; however, for the majority of patients experiencing nausea, it was mild to moderate, transient and manageable.
The results from the successfully completed COR program of more than 4,500 patients exceed the FDA categorical efficacy benchmark for clinically significant weight loss, supporting the Company's plan to file a New Drug Application with the FDA by the end of April
In September, Orexigen announced the data from the Phase 2b clinical trial of Empatic. The results of this trial demonstrated the following:
-- Patients completing 24 weeks of Empatic360 (bupropion SR 360mg/zonisamide SR 360 mg) therapy lost 9.9% of their baseline body weight compared to 1.7% for placebo patients (p<0.001). Importantly, mean weight loss for patients on Empatic continued to decline through the endpoint of the trial, with no evidence of a weight loss plateau. -- Improvements were observed in key markers of cardiometabolic risk, such as waist circumference, triglycerides, fasting insulin and blood pressure, compared to placebo. -- The most commonly reported adverse events, as well as those leading to discontinuation, for all Empatic patients were headache, nausea and insomnia. Adverse events and laboratory findings appeared to be consistent with the individual components of Empatic. There were no statistically or clinically meaningful differences between Empatic and placebo on measures of cognitive function, depression, suicidality or anxiety.
-- In July, the Company completed a public offering of 11.5 million shares of common stock at $7.50 per share, which resulted in net proceeds to the Company of approximately $81.6 million.
Time for some new 52 week highs before FDA approval!!!!!!!
With all the problems that Big pharma is having, nothing in the pipeline, generics, off label promotion i.e. law suites, manaufacture problems, Medicare/insurance payments, old and backwards promoting of the products, You cant tell me that someone does not want a product like this! OR a management team like this one. I disagree with a contract sales force. Doctors dont responed to a Sales rep that is there for the now. The management team is great but most have not sold a product in a Doctors office. Undercover Boss would be a great thing for Mike to make some sales calls. Instead of paying a Doctor to answer a survey, how about getting in the field and experience what your sales force will be dealing with day to day.